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J&J files new Darzalex formulation in US and Europe

Subcutaneous version could help fend of Sanofi rival


Johnson & Johnson has filed for approval of a subcutaneous injection version of its multiple myeloma drug Darzalex that could make dosing easier for patients and defend the franchise against a Sanofi rival.

J&J’s Janssen unit as asked for approval in the US and Europe of the new formulation of the anti-CD38 antibody, which can be delivered in just a few minutes, whereas the current intravenous infusion of Darzalex (daratumumab) takes several hours.

The shorter administration time is expected to be preferable for many patients and also make it possible for Darzalex to be given in community settings rather than always requiring a trip to hospital.

J&J has shown in phase 3 trials that the subcutaneous formulation is just as effective as IV Darzalex on myeloma response rates and the time patients live without disease worsening, while the new version also seems to cause fewer infusion-related reactions.

If approved, the subcutaneous form will also help J&J fend off a challenge to Darzalex from Sanofi, which recently filed for approval of its anti-CD38 candidate isatuximab in relapsed/refractory myeloma.

Isatuximab is delivered by a two-hour intravenous infusion, so might be expected to capture market share from Darzalex in that setting, although Darzalex still has the advantage of approval further up the treatment pathway in previously-untreated patients.

Sanofi has also said it thinks that isatuximab could be safer to use in patients with inflammatory diseases like asthma, as unlike Darzalex it is not associated with complement activation, and will also be suitable for use in Darzalex treatment failures as it targets a different part of the CD38 molecule.

The FDA and EMA filings come shortly after J&J recorded worldwide net sales of $774m for Darzalex in the second quarter of this year, a 51% increase that shows the drug is showing no signs of a slowdown four years after its first approval in relapsed/refractory myeloma.

The antibody was originally developed by Danish biotech Genmab, and last month J&J also took an option on a follow-up drug – HexaBody-CD38 – that the partners describe as a “next-generation” anti-CD38 antibody that could work in Darzalex failures and in additional indications.

Article by
Phil Taylor

22nd July 2019

From: Regulatory



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